FDA AIDS protest targets approval of Gilead’s prevention pill

“FDA: Safety Before Profits!”—Gilead’s application to expand use of its AIDS drug Truvada for use as HIV prevention pill in uninfected individuals alarms AIDS advocates who note FDA approval is unwarranted based on current clinical trials

In September, Nation’s largest AIDS group filed legal action against the FDA over its denial of AHF’s Freedom in Information Act request regarding any correspondence between the FDA and Gilead regarding its potential application for use of Truvada as a form of ‘Pre-exposure Prophylaxis’ (PrEP)

AHF to launch DC-area ad campaign asking, “FDA: What do you have to hide?” with ads in the Washington Blade, on Politico.com and as DC transit shelter ads; public invited to send e-letters to HHS Secretary Kathleen Sebelius asking she ensure an objective and thorough FDA review process

Advocates from AIDS Healthcare Foundation(AHF) hosted a protest at the headquarters of the Food and Drug Administration(FDA) Monday, January 23rd at 10:00am Eastern Time over the FDA’s refusal to release documents regarding its contact and correspondence with Gilead Sciences about the potential FDA approval of Gilead’s blockbuster AIDS drug Truvada for use as a form of HIV prevention in uninfected individuals. The FDA is now hastily considering approval of this drug despite numerous failed clinical trials, a move which many AIDS care providers and advocates believe is unwarranted based on the studies and would set a dangerous precedent.

“The approval of Gilead’s AIDS treatment Truvada for use as an HIV prevention pill carries serious health risks for uninfected individuals who will take it expecting to be fully protected,” said Michael Weinstein, President of AIDS Healthcare Foundation. “If FDA officials ignore these risks in favor of Gilead’s desire to fast-track approval in order to expand its market share, it will costs lives.”

In September 2011, AHF filed a legal action in the United States District Court, Central District of California, against the FDA over its denial of AHF’s Freedom in Information Act requests that asked for correspondence between the FDA and Gilead Sciences regarding its potential application for use of Truvada as a form of ‘Pre-exposure Prophylaxis’ (PrEP) in HIV-negative populations.

The advocates believed Gilead may have filed for FDA-approval for expanding the use of its best-selling $35 per day AIDS drug to include its use as a form of HIV prevention last summer following a widely-reported study released earlier that year. The study, of 2,500 high-risk gay men using Truvada as prevention, showed a 44% efficacy rate in preventing HIV transmission. AHF believes such modest trial results are insufficient to support FDA approval of Truvada as an HIV prevention tool—and a move that AHF and other AIDS advocates believe would set a dangerous precedent.

In response to AHF’s legal action, FDA officials filed a partial ‘motion to dismiss’ some elements of AHF’s FOIA request, and have requested specific information from AHF on the date or dates of Gilead’s application—some of the very information AHF was seeking in its initial FOIA requests.

On December 15, 2011, Gilead issued a press release formally announcing that it had filed an FDA application to expand use of Truvada as a form of HIV prevention, however, no date of the application was included in Gilead’s statement.

At Monday’s protest in Silver Spring, MD, 20 to 25 protesters will carry banners reading, “FDA: Safety Before Profits!”—Gilead’s PreP will cost lives!”
“Congress and Secretary of Health and Human Services Kathleen Sebelius must ensure that an objective and thorough FDA review process takes place and that serious consideration of Truvada for HIV prevention does not move forward without a full and transparent examination of the drug’s safety—as well as the FDA’s cozy relationship with Gilead,” added AHF’s Weinstein.

AHF Launches DC-area ad campaign, “FDA: What do You Have to Hide?”

In support of it action targeting the FDA and Gilead over possible fast-tracked approval of the AIDS drug Truvada for use as an HIV prevention pill, AHF is also launching a DC-area ad campaign asking, “FDA: What do you have to hide?” The campaign kicks off Friday January 20th with a print ad in the Washington Blade. The ad will then appear next all week on Politico.com (Jan 23-27) and as Washington, DC transit shelter ads starting January 23rd.

In addition, the public will be invited to send an e-letter to HHS Secretary Kathleen Sebelius asking she ensure an objective and thorough FDA review process to protect people who will be put at risk by PrEP’s approval for prevention.

Background on AHF’s Freedom of Information Requests to the FDA

According to AHF’s lawsuit, the action was, “…brought under the Freedom of Information Act, 5 U.S.C. Section 552, as amended, to enjoin defendants from withholding from public disclosure certain records of the United States Food and Drug Administration (“FDA”),” and seeks, “To enjoin the FDA from withholding FDA records,” and “To order the production of any FDA records improperly withheld from AHF.”

“AHF had heard from reliable sources that FDA officials were actually encouraging Gilead to apply for expanded use of its AIDS drug, Truvada, as a form of pre-exposure prophylaxis for prevention of HIV transmission,” said Michael Weinstein, AIDS Healthcare Foundation President. “We are disappointed in the fact that the FDA has failed to comply with these FOIA requests and filed the legal action after repeated failed attempts to get any answers from the FDA. This action was also filed to determine the extent of collusion, if any, between Gilead and the FDA with regard to this potential use for Truvada.”
According to AHF’s lawsuit, AHF filed the following FOIA requests and correspondence with FDA officials:

AHF Freedom of Information Request 2/25/2011

“AHF filed with the FDA’s Freedom of Information Office on February 25, 2011 a letter requesting access to certain documents, under the Freedom of Information Act, …that show whether, from January 1, 2010 to the present, Gilead Sciences Inc. has submitted an Investigational New Drug application and/or a New Drug Application and/or a request for a new use or indication for the use of the drug Truvada (Tenofovir/Emtricitabine) as a means of ‘pre-exposure prophylaxis’ to prevent transmission of Human Immunodeficiency Virus (HIV).”

AHF Freedom of Information Request 3/31/2011

“… Access was requested to “documents pertaining to or showing any communications or discussions, either within the FDA or between the FDA and Gilead Sciences Inc. concerning the possible indication for the use of the drug Truvada (Tenofovir/Emtricitabine) as a means of ‘pre-exposure prophylaxis’ to prevent transmission of Human Immunodeficiency Virus (HIV).”

FDA Denial of AHF’s Freedom of Information Requests

“​By letter dated July 18, 2011, the FDA responded to AHF’s two requests and assigned case numbers 2011-2612 and 2011-1543. … The FDA denied the requests, claiming that it “cannot acknowledge receipt of such applications until they are otherwise publicly disclosed, e.g., by the applicant or when an approvable or approval letter is issued to the firm.”

AHF Appeal

“​By letter dated August 25, 2011, AHF explained to the FDA that Gilead has made the status of any application public in a forum that included employees of the FDA and therefore the FDA’s purported basis for denying the Freedom of Information Act requests no longer exists….”
“The FDA did not respond to our appeal within the statutory time limit,” said Tom Myers, General Counsel and Chief of Public Affairs for AIDS Healthcare Foundation. “We believe pursuant to the Freedom of Information Act that AHF has the right to obtain the documents requested, and the FDA has no sound legal basis for its actions in withholding access to such documents. As a result of such ongoing avoidance and delay tactics and non-responses from the FDA, AHF decided its best course was to file this action in order to get the information requested.”